SFDA’s Guidance For Medical Device Maintenance Facilities
January 19, 2021
SFDA has recently published a Guidance For Medical Device Maintenance Facilities; Click here to read the official document.
Published on: 12th January, 2021
Highlights from this Document
This guidance is to clarify the Saudi Food & Drug Authority (SFDA) requirements on the maintenance services of medical devices and supplies in health facilities to ensure the performance of the medical device according to its intended purposes by applying calibration, planned preventative maintenance (PPM) and corrective maintenance (CM) during the usage of the medical device
This guidance applies to all medical devices maintenance facilities in the kingdom of Saudi Arabia (KSA).
Page 4 to 8 in the guidance is the requirements for Medical Devices Maintenance Facilities.
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